[2006] [1199] CANADIAN UROLOGIC ONCOLOGY GROUP (CUOG) PHASE II STUDY USING DOCETAXEL/PREDNISONE IN THE SECOND LINE SETTING FOR METASTATIC ANDROGEN INDEPENDENT PROSTATE CANCER IN PATIENTS PROGRESSING AFTER FIRST LINE MITOXANTRONE/PREDNISONE

Fred Saad*, Montreal, PQCanada; Dean Reuther, Calgary, ABCanada; Scott Ernst, London,, ONCanada; Scott North, Edmonton, ABCanada; Tina Chang, Calgary, ABCanada; Paul Perrotte, Pierre Karakiewicz, Montreal, PQCanada; Eric Winquist, London,, ON, Canada.

Introduction and Objective: Until recently the standard approved regimen for symptomatic androgen independent prostate cancer (AIPC) has been mitoxantrone/prednisone (MP). The regimen has proven efficacy in pain reduction and improvement in quality of life but has not shown survival benefit. No standard chemotherapy has been approved in the second line setting. Prior to the reporting of the phase 3 results of Tax 327 and SWOG 9916, phase II data showing efficacy with docetaxel/prednisone (DP) led to considering DP in patients progressing after prior MP and was the rational for this study. The objectives of the study were to determine the tolerability and response to docetaxel 75mg/m2 q 3 weeks plus prednisone 5mg BID in the second line setting in patients with metastatic AIPC having progressed after first line MP. Methods: Thirty patients (30) from 4 centres were included in the study. All patients had had prior MP for symptomatic, metastatic AIPC. Baseline PSA, pain scores, analgesic scores, bone scan and CT of the abdomen and chest were obtained. Patients all had castrate levels of testosterone and were maintained on LHRH therapy. Results: The study and analysis of results are still ongoing. Mean age was 70. Mean and median PSA at study entry was 363 and 112 respectively. At entry, 80% of patients reported having pain. At the last analysis of evaluable cases PSA reductions of greater than 50% was observed in 70% of patients. Some degree of pain improvement was observed in 80% of patients and analgesic scores were reduced in 57%. After 6 cycles, quality of life (Fact-P score) was significantly improved (p=0.04) compared to baseline. To date there have been 2 cases of febrile neutropenia and 14 deaths. Progression free survival is 7 months. The study has not yet reached median survival after 16 months, giving a median survival of over 24 months since beginning first line MP. Conclusions: Docetaxel is now considered to be the standard in metastatic AIPC. In patients who have previously received mitoxantrone it is reasonable to consider docetaxel in the second line setting. Tolerability of docetaxel in these patients appears to be comparable to that observed in patients receiving docetaxel as first line chemotherapy. PSA and symptom response is favourable.

Podium: Prostate Cancer: Advanced (II) (10:00 AM-12:00 PM)